Challenges in
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Supercritical fluid technology offers opportunities for pharmaceutical manufacturing but faces challenges for widespread adoption. It can be used for particle size reduction, drug delivery system design, and extraction. However, challenges include developing feasible scale-up designs, accurately modeling solute behavior, high capital costs of equipment, and difficulties producing products consistently at an industrial scale. Overcoming these challenges through continued research, development, and validation of continuous production processes could realize the full potential of this technology.
Challenges in
- 1. CHALLENGES IN SUPERCRITICAL FLUID TECHNOLOGY GUIDED BY:- PRESENTED BY:- Dr. Manish Patel Tejas Patel Associate Professor & HOD, M.Pharm:- III Department of Pharmaceutics . Roll No- 14 Departement of Pharmaceutics Nootan Pharmacy College, visnagar .
- 2. INTRODUCTION Supercritical fluids technology offer exciting opportunities to the pharmaceutical manufacturing scientists, as they cater to various processing needs. Supercritical fluid technology (SFT) has been used in many fields for decades, such as the food industry, chemical processing, polymers, textile, environmental forest product industries, the cleaning of precision parts Pharmaceuticals : Particle size reduction and Designing of Novel Drug Delivery Systems
- 3. They can be applied in a number of fields such as drug delivery, chromatography, synthesis, purification and extraction, providing efficient processes with increased yields, and selectivity as compared with conventional techniques. Entirely new technologies and modifications of existing technologies are being developed to address these needs. In the pharmaceutical field it has been widely used for the extraction of natural products like aromatic oils and caffeine, etc.
- 4. Newer areas of their application have appeared, such as particle size reduction (ultrafine powders of even thermolabile drugs) and designing of novel drug delivery systems (Solventless techniques for the preparation of microspheres, microcapsules, liposomes and designing of controlled drug delivery systems). For Pharmaceutical Scientist, Supercritical Fluid Technology offers tremendous potential for designing drug delivery systems and for other purposes in environmental and regulatory friendly manner. Also it is safe and economical.
- 5. BASIS OF SUPERCRITICAL FLUID TECHNOLOGY Supercritical Fluid (SCF) Technology is unique concept that exploits the solvent properties of Supercritical Fluids (SF). A solvent is stated to be supercritical when its pressure and temperature are higher than its critical temperature (Tc) and critical pressure (Pc). Beyond its Tc and Pc, no applied pressure can force the solvent into its liquid phase. At critical points, SCFs possess properties of both liquid and gas, with density values similar to those of liquids, and flow properties similar to those of gases, and are thus labelled as fluids. The physical and thermal properties of SCFs fall between those of the pure liquid and gas.
- 6. CHOICE OF SFs: A number of SCFs are available with a range of values for density and critical temperatures. The choice of the solvent is dictated by the physico- chemical properties of the compound of interest and role of solvent in the process in terms of solvency or anti-solvency. Although many SFs are suitable for pharmaceutical applications, the most widely used SF is carbon dioxide.
- 7. SFs have unique properties. SFs are non-flammable, non-toxic, inexpensive and do not require special disposal. SFs are abundantly available and readily available in high purity. SFs chemically inert in reactions. SFs act as media for variety of chemical reactions. Provide capability for manufacturing specially structured materials, which cannot be produced conventionally. Provide new capability for extraction, chromatography, and toxic waste elimination. Reduce biohazards since no solvent exposure hazard.
- 8. Ease of solvent removal Low handling costs Solvents used can be recovered and recycled Continuous process Additions of cosolvents and cosolute make the process more versatile and efficient Low operating conditions, temperatures and pressures are involved so suitable for thermally labile compounds
- 10. CHALLENGES IN SCF TECHNOLOGY Certain limitations however need to be overcome before realizing the full potential of supercritical fluids. Challenges facing successful implementation of this technology in practice include Feasible designs for scale-up are necessary for commercialization. Modeling for scale-up not always available/ accurate. Absence of fundamental, molecular-based model of solutes in SCF (to have detailed study on solute for example solubility study) and hence scale up operations may not be successful. Continuous instrumental & equipment improvements are required. Continuous research & development for applications & new material design is required.
- 11. Cont…… Elevated pressures requirement makes SCF Technology capital intensive business. A compression cost adds up. High capital equipment investment involved. The existing technologies are yet to be validated for continuous batch production. The utility of SCF technology in the future is highly dependent upon the ability to model and predict phase equilibria in complex systems.
- 12. Cont…… It is essential to understand the basic thermo physical processes that take place this will lead to development of reliable models and rational process designs possible. Difficulties are also associated with continuous production and harvesting of end product of desired characteristics consistently and reproducibly.